NCT02766088

This Study Will Describe the Burden of DENgue Fever Virus (DENV) Illness Among Household Members Aged 6 Months to 50 Years of Selected Communities in Latin America and Southeast Asia

Terminated NA Results posted Last updated 15 March 2024

What this trial tests

NA trial testing Blood sample collection in Dengue in 1,750 participants. Terminated before completion.

Timeline

14 July 2016

Primary endpoint
14 December 2018

14 December 2018

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	1,750
Start date	14 July 2016
Primary completion	14 December 2018
Estimated completion	14 December 2018
Sites	2 locations across Philippines, Mexico

Drugs / interventions tested

• Blood sample collection — full drug profile →

Conditions studied

• Dengue — all drugs for Dengue →
• Dengue Vaccines — all drugs for Dengue Vaccines →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 6 Months to 50, any sex, with Dengue or Dengue Vaccines. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Incidence Percentage of Reverse Transcriptase Quantitative Polymerase Chain Reaction (RT-qPCR) Confirmed Symptomatic Dengue Infection During the Study Period by Study Site Primary · From Day 0 to Month 24 (study end)

Incidence percentage of RT-qPCR confirmed symptomatic dengue infection was expressed as percentage of subjects = (n \[number of subjects with at least one event reported during the study period \]/N \[number of subjects in the population\]) X 100. The 95% Wald CI was calculated. Clustering effect was not retained because equal or less than 1. RT-qPCR confirmed symptomatic case = suspected dengue case (SDC) confirmed by RT-qPCR. See SDC definition in outcome 5.

Mexico

Group	Value	95% CI
Total Group	1.1	0.4 – 3.0

Philippines

Group	Value	95% CI
Total Group	0.8	0.3 – 2.1

Incidence Proportion of Virologically Confirmed Symptomatic Dengue Infection During the Study Period in Mexico Secondary · From Day 0 to Month 24 (study end)

Incidence proportion of virologically confirmed symptomatic dengue infection was estimated from GEE logistic regression model taking the clustering effect into account. The 95% confidence interval was based on the robust variance estimate from the GEE model. Clusters were households for analysis by study site. Virologically confirmed symptomatic case = suspected dengue case (SDC) confirmed by RT-qPCR or non-structural protein 1 (NS1). See SDC definition in outcome 5.

Group	Value	95% CI
Total Group	1.4	0.5 – 3.8

Incidence Percentage of Virologically Confirmed Symptomatic Dengue Infection During the Study Period in the Philippines. Secondary · From Day 0 to Month 24 (study end)

Incidence percentage of virologically confirmed symptomatic dengue infection was expressed as percentage of subjects = (n \[number of subjects with at least one event reported during the study period\]/N \[number of subjects in the population\]) X 100. The 95% Wald CI was calculated. Clustering effect was not retained because equal or less than 1. RT-qPCR confirmed symptomatic case = suspected dengue case (SDC) confirmed by RT-qPCR. See SDC definition in outcome 5.

Group	Value	95% CI
Total Group	0.8	0.3 – 2.1

Incidence Proportion of Probable Symptomatic Dengue Infection During the Study Period. Secondary · From Day 0 to Month 24 (study end)

Incidence proportion of probable confirmed symptomatic dengue infection was estimated from GEE model with clustering effect. Clusters were households for analysis by study site and study sites for analysis on overall study sites. A probable confirmed dengue infection is an SDC with DENV RT-qPCR negative or not performed (late presenter), and DENV NS1 negative or undetermined (early or late presenter), and Anti-DENV Immunoglobulin type M (IgM) positive with a rapid immunochromatographic (ICT) assay or an Enzyme-linked Immunosorbent Assay (ELISA) assay, or Anti-DENV IgG positive (rapid ICT assay

Group	Value	95% CI
Total Group	0	NA – NA

Proportion of Subjects With Dengue Virus Antibody IgG Positive Result (ELISA) at First Visit (Indicative of Past DENV Infection), by Study Site and Age Category. Secondary · At Day 0

The proportion of subjects with Dengue Virus antibody IgG positive result (ELISA) was estimated from GEE model with clustering effect. The 95% CI was based on the robust variance estimate from the GEE model. Clusters were households for analysis by study site. Ages categories were defined as follows: "6 months -\<12 Months" = from the 6 Months birthday up to and including the day before the 1st year birthday, and the next "n-p Years" categories = from the nth Year birthday up to and including the day before the (p+1)th Year birthday. Analysis was not summarized for confirmed and probable dengu

Mexico- 6 months -12 months

Group	Value	95% CI
Total Group	0	NA – NA

Mexico- 5-8 years

Group	Value	95% CI
Total Group	11.8	4.5 – 27.5

Mexico- 9-17 years

Group	Value	95% CI
Total Group	16.6	9.8 – 26.6

Mexico- 18-50 years

Group	Value	95% CI
Total Group	27.2	19.8 – 36.2

Philippines- 1-4 years

Group	Value	95% CI
Total Group	31.2	21.7 – 42.7

Philippines- 5-8 years

Group	Value	95% CI
Total Group	51.5	40.8 – 62.0

Philippines- 9-17 years

Group	Value	95% CI
Total Group	92.0	86.4 – 95.4

Philippines- 18-50 years

Group	Value	95% CI
Total Group	99.3	95.4 – 99.9

Percentage of Subjects With Dengue Virus Antibody IgG Positive Result (ELISA) at First Visit (Indicative of Past DENV Infection), by Study Site and Age Category. Secondary · At Day 0

The percentage of subjects with Dengue Virus antibody IgG positive result (ELISA) was expressed as percentage of subjects = (n \[number of subjects with at least one event reported during the study period\]/N \[number of subjects in the population\]) X 100. The 95% Wald CI was calculated. Clustering effect was not retained because equal or less than 1. Ages categories were defined as follows: "6 months -\<12 Months" = from the 6 Months birthday up to and including the day before the 1st year birthday, and the next "n-p Years" categories = from the nth Year birthday up to and including the day

Mexico- 1-4 years

Group	Value	95% CI
Total Group	6.4	2.1 – 18.0

Philippines- 6 months -12 months

Group	Value	95% CI
Total Group	8.3	1.2 – 41.3

Number of Suspected Dengue Cases With Temperature and Any Symptom From First and Returned Visits Secondary · From Day 0 to Month 24 (study end)

The following characteristics were summarized for each category of dengue cases (Virologically confirmed, probable, other SDC): Temperature at first visit: \<37.5, ≥37.5, \>38, \>38.5, \>39 °C and Clinical symptoms at onset, from first and returned visits. The results are presented for the virologically confirmed cases (VDC) and the other SDC (oSDC), no probable cases being reported in the study.

Temperature <37.5 °C VDC

Group	Value	95% CI
Total Group	5

Temperature ≥37.5 °C VDC

Group	Value	95% CI
Total Group	4

Temperature >38.0 °C VDC

Group	Value	95% CI
Total Group	4

Temperature >38.5 °C VDC

Group	Value	95% CI
Total Group	1

Temperature >39.0 °C VDC

Group	Value	95% CI
Total Group	0

At least one main sign VDC

Group	Value	95% CI
Total Group	9

Fever VDC

Group	Value	95% CI
Total Group	9

Headache VDC

Group	Value	95% CI
Total Group	7

Number of Suspected Dengue Cases With Severity Criteria Characteristics Secondary · From Day 0 to Month 24 (study end)

The clinical classification of the suspected dengue cases were distributed among following categories: Subject hospitalized during suspected dengue episode; OR At least 1 WHO 2009 warning signs: i.e. Abdominal pain or tenderness, Persistent vomiting, Clinical fluid accumulation, Mucosal bleed, Liver enlargement, Increase in HCT concurrent with rapid decrease in platelet count, Lethargy and restlessness; OR At least 1 WHO 2009 criteria for severe dengue: i.e. Severe Plasma Leakage leading to Shock, Fluid accumulation with respiratory distress, Severe Bleeding, Severe organ involvement; Liver: A

Subject hospitalized VDC

Group	Value	95% CI
Total Group	0

At least 1 WHO 2009 warning signs VDC

Group	Value	95% CI
Total Group	5

At least 1 WHO 2009 severe dengue criteria VDC

Group	Value	95% CI
Total Group	0

Most likely diagnosis: Dengue VDC

Group	Value	95% CI
Total Group	7

Most likely diagnosis: Chikungunya VDC

Group	Value	95% CI
Total Group	0

Most likely diagnosis: Influenza VDC

Group	Value	95% CI
Total Group	0

Most likely diagnosis: Malaria VDC

Group	Value	95% CI
Total Group	0

Most likely diagnosis: Leptospirosis VDC

Group	Value	95% CI
Total Group	0

Number of Subjects With Serious Adverse Events (SAEs) Related to a Study Procedure Secondary · From Day 0 to Month 24 (study end)

Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject..

Group	Value	95% CI
Total Group	0

Sponsor's own description

The purpose of this study is to describe the burden of DENV illness among household members aged 6 months to 50 years of selected communities in Latin America and Southeast Asia.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Incidence of dengue illness in Mexican people aged 6 months to 50 years old: A prospective cohort study conducted in Jalisco.
   DeAntonio R, Amaya-Tapia G, Ibarra-Nieto G, Huerta G, et al · · 2021 · cited 7× · PMID 33951076 · DOI 10.1371/journal.pone.0250253
2. Assessing the burden of dengue among household members in Alaminos, Laguna, the Philippines: a prospective cohort study.
   Capeding MR, de Boer M, Damaso S, Guignard A. · · 2021 · cited 2× · PMID 37551324 · DOI 10.2478/abm-2021-0027